NCT01537471

Brief Summary

The purpose of the investigators research is to test whether problems people have with processing their senses (feeling overwhelmed, distracted or upset by sounds and other stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines, which are medicines used for things like allergies, sleep problems, or the common cold.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

February 1, 2012

Last Update Submit

January 15, 2013

Conditions

Healthy

Keywords

PPIMeclizineStartleSensory processingantihistamines

Outcome Measures

Primary Outcomes (1)

  • Change in PPI

    The primary outcome will measure change in subjects' PPI depending on whether they were given meclizine during the study. Prepulse inhibition (PPI) of the startle reflex by a weak pre-pulse will be assessed during each laboratory session. It is measured using electromyographic (EMG; i.e., for assessing eye blink magnitude) responses.

    Screening Day 1, Days 2-4

Secondary Outcomes (1)

  • Sedation

    Day 2, Day 3, & Day 4

Study Arms (2)

Placebo

OTHER

A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. On one of three visits, a subject will receive placebo. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.

Drug: Placebo

Meclizine

EXPERIMENTAL

A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. By the time they finish, they will have all received placebo, 12.5mg meclizine and 25mg meclizine. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.

Drug: Meclizine

Interventions

PlaceboDRUG

Placebo

Also known as: Sugar Pill
Placebo
MeclizineDRUG

Meclizine 12.5 mg

Also known as: Antivert, Dramamine II, Bonine, Medivert
Meclizine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males or females
  • Startle response \>0.5
  • PPI \< 32
  • CO level \<8ppm

You may not qualify if:

  • Tobacco or nicotine use within 2 weeks of screening
  • Current or history of a neurological disorder of neurological event
  • Negative response to antihistamine use in past
  • ECT treatment in the past 6 months
  • Current or past history of manic or hypomanic episodes (SCID-I)
  • Current or history of psychotic disorder
  • Current alcohol or substance abuse/dependence
  • Positive urine drug test
  • CO level of \>8ppm
  • Startle \<0.5 \& overall PPI \>32 (assessed during study)
  • Significant hearing problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

  • Braff D, Stone C, Callaway E, Geyer M, Glick I, Bali L. Prestimulus effects on human startle reflex in normals and schizophrenics. Psychophysiology. 1978 Jul;15(4):339-43. doi: 10.1111/j.1469-8986.1978.tb01390.x. No abstract available.

    PMID: 693742BACKGROUND

  • Castellanos FX, Fine EJ, Kaysen D, Marsh WL, Rapoport JL, Hallett M. Sensorimotor gating in boys with Tourette's syndrome and ADHD: preliminary results. Biol Psychiatry. 1996 Jan 1;39(1):33-41. doi: 10.1016/0006-3223(95)00101-8.

    PMID: 8719124BACKGROUND

MeSH Terms

Interventions

SugarsMeclizine

Intervention Hierarchy (Ancestors)

CarbohydratesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mark Z Rosenthal, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Ed Levin, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 23, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)